St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced that its Trifecta™ biological pericardial aortic valve has demonstrated positive results in a new study published online in The Journal of Thoracic and Cardiovascular Surgery. The Trifecta valve was evaluated in patients who required aortic valve replacement surgery. The results highlight the outstanding hemodynamic performance of the Trifecta valve (the ability to maximize blood flow through the valve), further confirm safety, and describe its ease of use. This study is one of the largest, multi-center, prospective studies ever conducted on a surgical aortic heart valve.
“The Trifecta valve provides an exceptional hemodynamic profile and the strong clinical results support outstanding one-to-two-year performance data. Additionally, the valve has shown minimal leakage,” said Dr. Bavaria. “I have used this valve for more than five years and have found it easy to implant and very reliable, making it an excellent choice for managing patients who require valve replacement.”Additional Findings:
- Uniformly low gradients (a reduction in pressure exerted on the heart as blood flows through the valve) indicates exceptional valve function across all sizes for a stented tissue heart valve.
- Favorable hemodynamics in the Trifecta valve led to a uniquely low incidence of severe prosthesis-patient mismatch (when the size of the valve’s flow area is too small in relation to the patient’s body size) with 94.8 percent of patients free from this condition at one year.
- Improved blood flow through the Trifecta heart valve leads to a significant decrease in left ventricular (LV) mass (or thickening of the heart muscle) over the course of one year. High LV mass is one of the most important predictors of heart failure, cardiovascular morbidity and mortality.
- An extremely low rate of paravalvular leak (blood leakage around the area where the valve is sewn in place) and minimal valve regurgitation (a backflow of blood from the aorta into the left ventricle) was reported.
- Despite the advanced age of patients and their high risk profile, study results demonstrated a survival rate of 94.5 percent at two years, which compares favorably to comparative technologies.